BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer

BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment of metastatic breast cancer.

The US-based clinical-stage biotech company specializes in targeted immunotherapies for cancer.

Bria-IMT is a cell-based immunotherapy, which has been designed to preferentially kill tumor cells without damaging the normal cells.

Presently, BriaCell Therapeutics is enrolling and dosing patients with advanced breast cancer in its phase I/IIa combination study of Bria-IMT with a checkpoint inhibitor called retifanlimab and an immunomodulator called epacadostat, both owned by Incyte Corporation.

According to BriaCell Therapeutics, initial findings on patient survival in the phase I/IIa study was presented originally at the San Antonio Breast Cancer Symposium in December 2021 and was over 12 months compared with 7-10 months in a study in 3rd line breast cancer patients.

Commenting on the fast track status of Bria-IMT, Dr. Del Priore — BriaCell Therapeutics Chief Medical Officer said: “We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer. We continue to move forward with the clinical evaluation of Bria-IMT towards a potential registration study to bring hope to patients living with this deadly disease.”